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NATIONAL ISOTOPE PRODUCTION FACILITY IS NEEDED

Executive Summary

NATIONAL ISOTOPE PRODUCTION FACILITY IS NEEDED "to alleviate a dangerous uncertainty of supply" of radioactive and stable nuclides in the U.S., MediPhysics Chairman John Kuranz testified at an Aug. 12 hearing of the House Government Operations/Environment subcommittee. Speaking on behalf of the Council of Radioisotopes and Radiopharmaceuticals (CORAR), Kuranz explained that "due to the high costs and risks of operating reactors, and significant regulatory issues surrounding the construction and operation of a reactor in the U.S., most U.S. [radiopharmaceutical] companies have to turn to the outside for supply" of isotopes needed to develop their products. CORAR is comprised of Bristol-Myers Squibb, DuPont Merck, DuPont, Mallinckrodt Medical and Medi-Physics. Kuranz commented that the U.S. Department of Energy "has the capability for the most part [of] operating reactors and other facilities available to provide" radioactive and stable nuclides used to produce radiopharmaceuticals. "However, [DoE's] performance as a reliable, efficient, and cost-competitive supplier of radionuclides to industry has not been demonstrated." Problems associated with the U.S. radiopharmaceutical industry's dependence on foreign isotopes, he said, were highlighted in July when a labor dispute at Atomic Energy of Canada Ltd. threatened to close down operations. The Canadian firm Nordion International produces "most of the world's requirement for" nuclide Molybdenum-99 using a reactor complex owned by AECL, Kuranz explained. "If these operations are restricted or impaired," as would have been the case if the AECL labor strike was not averted, "the lack of a reliable supply of Mo-99" and other radioisotopes "would trigger a health care crisis in hundreds of nuclear medicine clinics," Kuranz argued. Representing the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) at the hearing, Richard Reba, MD, added that "the unavailability of isotopes [in the U.S.] stifles product research, development, and marketing, resulting in yet another hurdle that American business must overcome." Nuclear medicine researchers also "are unable to pursue many of their ideas for medical advances due to the uncertain supply of radioisotopes," Reba said. To mitigate U.S. dependence on foreign isotope suppliers, Reba cited the importance of developing a national biomedical tracer facility (NBTF), a federally funded component of DoE that would be dedicated to producing isotopes for radiopharmaceutical firms and nuclear medicine research. Reba noted that NBTF could "recoup a portion of its operating costs through the production and sale of isotopes." The nuclear medicine expert noted that SNM and ACNP asked Congress to earmark $2 mil. under the fiscal 1993 energy and water appropriations for the siting and development of the NBTF. CORAR also has supported this funding. Although the $2 mil. was not included in the House or Senate appropriation bills, language on the NBTF may be included in the energy and water appropriations conference report. Reba told the subcommittee that at least seven sites, including national laboratories and educational institutions, are interested in housing the NBTF and recommended that a request for proposal for the facility be initiated as soon as possible to "determine where the NBTF would be best located." Nuclear medicine groups and industry have been working with DoE since the early 1980s to develop a dedicated U.S. facility for biomedical tracer production and research. As part of this effort, SNM conducted a feasibility study on the NBTF under a DoE grant. The study, which included input from industry, was presented to Congress in 1991. The study concludes that "the deteriorating state of nuclear reactors at DoE national laboratories, coupled with the shutdown [in 1990] of the sole remaining commercial reactor" in the U.S. that supplied radioisotopes for medicine -- Tuxedo, N.Y.-based Cintichem -- "has forced us to become dependent on foreign suppliers." The report notes that a possible solution to this problem is to create radionuclides in particle accelerators rather than reactors. The NBTF could provide a site for research on developing accelerator-produced isotopes that could take the place of reactor-produced isotopes that are currently favored by industry, the report says. The Aug. 12 hearing, convened by Subcommittee Chairman Synar (D-Okla.), was the first congressional session to examine exclusively how the IP&D's organizational and financial difficulties affect industry and the medical and research communities. Rep. Synar promised that additional hearings would be held next year to explore how "to fulfill the need for an assured supply of isotopes in the U.S."
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